FDAClass IIDecember 28, 2016

FLEXI NOZZLE SHORT Product Usage: These products are recall

FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal…

Why was FLEXI NOZZLE SHORT Product Usage: These products are recalled?

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code: MAD510L, Lot# 160118, 160324, 160509, 160709, 160810 and 160833.

Product
FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal…
Recalling firm
Teleflex Medical
Quantity
2,674,650 units in total
Distribution
Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.
Recall date
December 28, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls